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The goal of this clinical trial is to compare ZX-7101A in Chinese Adults patients with uncomplicated influenza. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZX-7101A low dose group | Experimental | 40 mg, tablet, single oral administration when the subject screened successfully |
|
| ZX-7101A high dose group | Experimental | 80 mg, tablet, single oral adminitration when the subject screened successfully |
|
| Placebo control | Placebo Comparator | Analog tablet with no active ingredient, single oral administration when the subject screened successfully |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZX-7101A | Drug | a drug to treatment influenza in Chinese adults |
|
| Measure | Description | Time Frame |
|---|---|---|
| The time to the remission of all influenza symptoms (hours) | Defined as the time from the start of study treatment to the time all flu symptoms are relieved. Symptom relief was defined as all seven influenza symptoms assessed by the subject on the subject diary card(Stuffy nose, sore throat, cough, muscle or joint pain, fatigue, headache, fever or chills/sweating) were 0 (asymptomatic) or 1 (mild); | from accepting ZX-7101A until the 15 days after the first dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | The Number of Participants with Treatment-Related Adverse Event will be evalated as the change of vital signs, electrocardiogram (P Wave, QRS Complex, QT Interval), physical examination, and Laboratory test compared with the baseline. | from accepting ZX-7101A until the 15 days after the first dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| hong wen Zhang, doctor | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Affiliated to Fudan University | Shanghai | China |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |